Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

K181289 is the FDA 510(k) clearance record for Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System, a class II device, cleared for Cepheid on 2018-08-15 under FDA product code OCC (Respiratory Virus Panel Nucleic Acid Assay System). FDA's definition for product code OCC reads: "A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The...". FDA records list 62 510(k) clearances for Cepheid, from 2006-07-25 to 2026-08-07. As of 2026-09-10, FDA records show no recalls naming K181289.